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Phase I clinical trials program offers patients unique opportunity

The Phase I team

The Arizona Cancer Center's Phase I Clinical Trials Program is the only place in Southern Arizona where patients can get access to cutting-edge investigational treatments.

"The future is here," said Daruka Mahadevan, MD, PhD, director of the Phase I Clinical Trials Program and Drug Development and Translational Research at the Arizona Cancer Center. "The existing drugs are useful, but we can do better with new drugs to keep our patients alive."

The Phase I program tests new targeted therapies for the first time in small groups of patients to evaluate safety, determine safe dosages and identify side effects. Targeted therapies are drugs that block the growth and spread of cancer by interfering with molecules involved in tumor growth and progression. By targeting cancer-specific changes in the body, targeted therapies may be more effective against cancer and less harmful to healthy cells than traditional treatments.

It’s clear that the newer targeted therapies work, because people participating in the Phase I studies are often living longer, said Dr. Mahadevan. He frequently treats patients with tumors that would have been considered difficult to control in the past, but now have a positive clinical response and benefit.

"These people have failed two or more front-line therapies and they're expected to die in two or three months, but they’re living a year or more," he said. "We are actually increasing their survival, even in a Phase I trial."

Another benefit of the new drugs is that they lack the limitations and side effects of some traditional treatments.

"Patients on Phase I trials of targeted therapies can continue to take the drug as long as there is a clinical benefit," Dr. Mahadevan said. "With chemotherapy you cannot do that. Chemotherapy can only be given for a certain amount of time and then you stop because the body can't handle it. You're done. With these new kinds of treatment, that's not the case. The body can handle it because they are targeted therapies."

Additionally, patients who no longer show a response on one Phase I trial, can go on to another.

"Often times they go from one study to another study," said Ruth Cañamar, the Phase I Clinical Trials Program manager. "Our patients can participate in several trials. That's the benefit of coming to a cancer center such as ours; you're seeing the leading experts in cancer care and you have access to treatments you can’t get anywhere else."

Because the new investigational drugs are proving to be more effective while at the same time reducing the harmful and uncomfortable side effects often associated with standard treatments, Dr. Mahadevan recommends more patients consider Phase I studies earlier in their cancer treatment.

"Phase I is a bridge to better therapies," he said. "Patients should come here before it gets to the last-ditch effort. It’s futile to go down third-line and fourth-line standard of care drugs when there are actually new drugs that are less toxic and that may be more beneficial. They could get these new drugs and always go back to third-line, fourth-line drugs, but once they’ve exhausted all the standard of care options, they’re often not fit enough to go on a Phase I trial."

Rigoberto Ruiz could be the poster child for Phase I clinical trials. In February 2002, he had his first surgery for a gastrointestinal stromal tumor, a rare cancer affecting the digestive tract and nearby abdominal structures, and he has been in six Phase I studies since. For years, he has driven from Sierra Vista every two weeks for treatment at the Arizona Cancer Center.

"He was dying," Dr. Mahadevan said. "It was eating him alive. Now when you look at him, he looks good."

Ruiz’s tumor has regressed significantly since he began treatment in his current Phase I trial. The study drug he’s taking now causes no side effects and leaves him with plenty of energy to take walks with his two 2-year-old grandchildren every day.

"This medicine helps a lot," said Ruiz, who has been very pleased with the medical attention he has received and recommends Phase I trials to other patients.

"I tell them to do it," he said. "Everybody needs to take every chance to live."

The Arizona Cancer Center is working with regional doctors to increase referrals to the Phase I program.

"Community physicians can use this opportunity to get the best care for their patients," Cañamar said. "Their patients will go back to them, but if they're treated here, they're going to get an expert opinion and treatment with drugs they can't get anywhere else. This is the place to go. Our physicians are the leaders in their fields."

All clinical trial candidates are given extensive information about the study and its potential benefits and risks before enrolling, but Dr. Mahadevan said those who really understand what Phase I trials are about are almost always interested in taking part.

"If physicians talk to their patients openly about the biology and complexity that we’re dealing with, in that setting patients are very keen to go into studies," he said.

Since the program began three years ago, the Arizona Cancer Center has treated 115 patients in 15 industry-sponsored Phase I clinical trials.

"We have conducted a number of first-in-human studies where we were the first on the planet to give the treatment to a patient," Dr. Mahadevan said.

Thus far, all Phase I trials at the Arizona Cancer Center have been outpatient only, though soon the program will be able to run inpatient trials as well. University Medical Center, the Cancer Center’s clinical partner in Tucson, is opening a new inpatient oncology wing that will be able to meet the needs of Phase I inpatient studies.

"There are some Phase I studies that have an inpatient component," Dr. Mahadevan said. "Now if we need it, we have access to that service. It’s part of the expansion."

With its current staffing and funding levels, the Phase I program can run up to 10 trials concurrently, but Dr. Mahadevan would like to increase that number – a goal that is purely patient-focused. Having more physician researchers and research nurses on staff would allow the Arizona Cancer Center to offer more Phase I trials of promising new drugs to more patients from across the state and the nation.

"Our top priority," he said, "is to serve patients with the best possible drugs."